Efficacy and Safety of Once-Daily Dapsone Gel, 7.5% for Treatment of Adolescents and Adults With Acne Vulgaris: Second of Two Identically Designed, Large, Multicenter, Randomized, Vehicle-Controlled Trials

August 2016 | Volume 15 | Issue 8 | Original Article | 962 | Copyright © 2016

Lawrence F. Eichenfield MD,a Ted Lain MD,b Ellen H. Frankel MD,c Terry M. Jones MD,d Joan-En Chang-Lin PhD,e David R. Berk MD,e Shiling Ruan PhD,e and Alexandre Kaoukhov MDe

aUniversity of California, San Diego and Rady Children’s Hospital, San Diego, CA
bPrivate Practice, Austin, TX
cRISkinDoc, Cranston, RI
dDermatologe, Bryan, TX
eAllergan plc, Irvine, CA

Abstract

BACKGROUND: Dapsone gel, 5% is administered twice daily for the treatment of acne vulgaris, and some patients may find adherence challenging.
OBJECTIVE: The study objective was to assess the efficacy and safety, compared with vehicle, of acne treatment with a recently FDA-approved, once-daily formulation of dapsone gel, 7.5%, with a 50% greater concentration of dapsone.
METHODS: This 12-week, randomized, double-blind, vehicle-controlled, multicenter clinical trial enrolled patients aged 12 years and older with 20–50 facial inflammatory lesions, 30–100 facial noninflammatory lesions, and an acne grade of 3 (moderate) on the Global Acne Assessment Score (GAAS). Patients were randomized (1:1 ratio) to topical dapsone gel, 7.5% or vehicle once daily for 12 weeks. Investigators assessed GAAS success rate (proportion of patients with a GAAS of 0 or 1) and percent change from baseline in inflammatory, noninflammatory, and total lesions.
RESULTS: The intent-to-treat population comprised 2238 patients (1118 in the dapsone gel, 7.5% group and 1120 in the vehicle group). The GAAS success rates were 29.8% for the dapsone gel, 7.5% group and 20.9% for the vehicle group (P<0.001) at week 12. At week 12, mean inflammatory lesions decreased from baseline by 53.8% and 47.3%, noninflammatory lesions decreased by 45.9% and 40.4%, and total lesions decreased by 48.9% and 43.2% for the dapsone gel, 7.5% group and the vehicle group, respectively (all, P<0.001). The incidence of treatment-emergent adverse events was similar for dapsone gel, 7.5% (17.6%) and vehicle (17.1%). Most adverse events were mild to moderate in severity. The most frequently reported increase in severity for all of the dermal tolerability scales was from “none” to “mild.”
CONCLUSION: Dapsone gel, 7.5% applied topically once daily is an effective, safe, and well-tolerated treatment for acne vulgaris. Improvements in acne severity and lesions were observed over the 12-week course of treatment.

J Drugs Dermatol. 2016;15(8):962-969.

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INTRODUCTION

Acne vulgaris (acne), a common dermatologic disorder in adolescents and adults,1 can negatively impact an individual’s quality of life and psychological well-being.2-4 Effective treatment of acne symptoms may improve quality of life and reduce depression and anxiety symptoms in individuals with acne.2,5

Dapsone, a sulfone compound with anti-inflammatory properties, is used as a topical treatment for a number of dermatologic conditions.6-9 Dapsone gel, 5% (Aczone® Gel, 5%; Allergan plc, Dublin, Ireland) was approved in 2005 for use as a twice-daily topical treatment for acne.10,11 Clinical trials have demonstrated that dapsone gel, 5% was effective compared with placebo, was well tolerated with a safety profile similar to that of vehicle, and that effectiveness was sustained throughout 1 year of open-label treatment.12,13 Systemic absorption of dapsone following topical treatment with dapsone gel, 5% is minimal; systemic exposure to dapsone and its primary metabolites following twice-daily application is expected to be approximately 1% of that from daily oral administration of dapsone 100 mg.14

Poor adherence is common with long-term management of acne15-17 and may result in an increased risk of treatment failure.15,18 Factors that influence adherence include age, severity of disease, knowledge about acne, the profile and severity of treatment side

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